Home NDC 51407-705 Fludrocortisone acetate
Product NDC 51407-705
11-digit product format 514070705
Labeler code 51407
Product ID 51407-705_3d863fa4-bdeb-e0a4-e063-6294a90a7cc4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludrocortisone acetate
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA219251
Marketing category ANDA
Marketing start 2024-10-16
Substance FLUDROCORTISONE ACETATE
Active strength .1 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219251-001 FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219251-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219251-001 FLUDROCORTISONE ACETATE 0.1MG TABLET / ORAL AB 2024-10-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fludrocortisone acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUDROCORTISONE ACETATE .1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V47IF0PVH4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313979 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51407-705-01 Fludrocortisone acetate 100 in 1 BOTTLE TABLET 100 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51407-705-01 51407070501 100 TABLET in 1 BOTTLE (51407-705-01) 100 tablet 2025-06-10 No No Current